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The Society of Thoracic Surgeons' National congenital heart surgery database
REPORT
The Society of Thoracic Surgeons' National Congenital Heart Surgery Database the May 1990 meeting of The Society of Thoracic A t Surgeons' (STS) Ad-Hoc Committee to Develop a National Database for Thoracic Surgery, a special subcommittee was named by Chairman Richard Clark to develop a database for congenital heart surgery. During the course of many meetings, several database formats were considered and discarded; in April 1993 consensus was achieved and the current database collection form was finalized and made available to those interested in purchasing the program from Summit Medical Systems. Why a national database for congenital heart surgery? Extant databases embrace congenital heart surgery; however, congenital heart surgery data collection is incidental to their primary data collection objectives and a significant subgroup of the congenital heart surgery population is excluded from the various databases; eg, neonatal databases exclude older patients; university hospital databases exclude those patients operated on in nonuniversity hospital settings. State governments are inconsistent in their legislative mandates and funding for data collection; not all states mandate health data collection and, of those, the mandates vary from expansive (and expensive) data collection to narrowly defined data collection for specific disease entities or population subsets. With increasing pressure placed on practitioners by third-party agencies (governmental and private) to provide reliable data on surgical experience, the STS Database Committee charged the subcommittee to develop a database that would (1) provide a reliable count of congenital heart surgical procedures and (2) provide outcome data with the potential for risk factor analysis. The initial database collection form was modeled after the STS Adult Cardiac Surgery form; there are sections on demographics, patient history, diagnosis, procedure, cardiopulmonary bypass and support data, and postoperative data, with items within each category that were agreed upon by the subcommittee as being significant to congenital heart surgery data collection and analysis. The alpha test site of the first Summit Medical Systems version of the Congenital Heart Surgery Database program was Children's Memorial Hospital, Chicago, in October 1991. Subsequent major conceptual and minor fine-tuning revisions to the database were made as a result of problems that arose at the alpha site when the database program had to be adapted to the realities of the complex congenital heart surgery patient population. Among the conceptual issues that needed defining by the subcommittee were the following: is a separate database form to be completed for each procedure or for each hospitalization period; how does one differentiate and Address reprint requests to Dr Mavroudis, Division of CardiovascularThoracic Surgery, The Children's Memorial Hospital, 2300 Children's Plaza-M/C #22, Chicago, IL 60614.
© 1995 by The Society of Thoracic Surgeons
weight the multiple diagnoses some of the congenital heart patients have--is one diagnosis more significant than another, are two diagnoses significant and four others less so; how does one portray the patient who has had an operation for one diagnosis in the past and now is admitted for another operation for a different problem; how does one differentiate from many potential diagnoses the diagnosis that drives the current procedure; how does one compile a procedure list--by providing hundreds of specific isolated procedures and combinations of procedures, or by providing components so that the procedure can be built from components into a whole; and how does one indicate a second or third procedure performed during a hospitalization period? If a separate database form is completed for each procedure, complete information is acquired surrounding the events of the procedure. However, for a child requiring two operations in one admission, the whole may be greater than the sum of its parts. Were the operations staged, planned procedures or reoperations for residual defects or rescue procedures? In calculating length of stay data, if two separate forms were used, the length of stay data for the specific procedure would skew future length of stay analysis of that procedure. The subcommittee decided that the hospital admission was the definer of the database collection form, not the individual procedure, recognizing that in some instances data relevant to particular procedures would be lost (eg, when a closed heart procedure was performed first and an open heart as the second procedure, the cardiopulmonary bypass data would be sacrificed). The concept of applying a primary or secondary label to a diagnosis was arrived at easily by the subcommittee, and it was agreed that there could be more than one primary diagnosis. A remote repair designation was developed to indicate a diagnosis repaired in the past that is not being addressed at the current procedure but is still significant to an understanding of the patient's condition, ie, a patient who has undergone an arterial switch procedure in the past for transposition of the great arteries but who is now admitted for an operation to relieve pulmonary stenosis. The transposition of the great arteries is a remote repair diagnosis, the pulmonary stenosis the primary diagnosis. Another challenge to the subcommittee was how to designate, in the instances where a patient has multiple diagnoses, which of the diagnoses were being addressed by the current procedure. The section on diagnosis for current procedure was devised to accurately depict which diagnosis was being addressed by the operation. The subcommittee recognized that although the section is redundant for patients with isolated defects, it is Ann Thorac Surg 1995;59:554-6 • 0003-4975/95/$9.50 0003-4975(94)00947-6
Ann Thorac Surg 1995;59:554-6
important for infants and children with complex multiple defects. After work was done for some months at the alpha site with a lengthy list of procedures, it became clear that the list had the potential for unlimited expansion and would quickly become unwieldy; therefore, the subcommittee decided upon a component approach to the procedure section that would allow flexibility in coding without length. A Rastelli procedure, for instance, would include a ventricular septal defect closure and conduit placement. The ventricular septal defect closure field and the valve and valved conduit field allowed specifics of the techniques to be entered that a single field for Rastelli would not have allowed without multiple listings. Within the component field the subcommittee also arrived at the solution to the problem a second, or third, procedure within a hospitalization posed for the database. If a subsequent procedure was done it could be entered within the components as 2nd Op (or 3rd Op if necessary). As we write this, changes have been approved to the database collection form and program, most notably the ability to link in the report-making capability of the database a patient's name and a short diagnosis/procedure characterization. As entries and analyses of data are made nationally, changes and corrections to the current form may be necessary. The Subcommittee has agreed that suggested amendments to the collection form be reviewed on a yearly basis.
Personnel Accurate and complete data collection, consistent data entry, objective data analysis, and timely data maintenance are the cornerstones of an effective patient database. In telephone surveys of the first 30 users of the database, the subcommittee found that the individual cardiac surgery practices used office, nursing, and hospital technical staff to perform data collection and data entry. In some practices, a physician assistant or registered nurse gathered all data; in others, demographic data were completed by office staff, preoperative and postoperative data were gathered by fellows or resident staff, and intraoperative data were provided by perfusionists. Many practices had more than one database tracking different patient populations (adult cardiac surgery, adult thoracic surgery, cardiac transplantation, congenital cardiac surgery) and it was more usual for these groups to have one full-time person responsible for data collection, data entry, and data analysis. Selecting one person to be responsible for coordination of data entry and data analysis emerged as one of the most important means of assuring valid and reliable data entry and retrieval. Particularly in those practices that relied on short-term fellow or resident staff to complete data forms, it was found that data quality and consistency varied with changes of personnel. By having one data entry person capable of assessing and completing/editing/correcting data forms, data reliability could be assured. Summit Medical Systems has a training program for the individ-
REPORT STS CONGENITALHEARTSURGERYDATABASE
555
Table 1. Data Analysis Menu
Search/listing reports menu Frequency tables menu Population summary reports Biostatistics menu Presentation graphics Define population subset Define module relationships Predefined reports Return to access menu
uals who will be the primary users of the database available at their homesite in Minnesota, and this program is helpful, especially for those centers requiring customization of their database or sophisticated report formatting or data analysis.
Report-Making Capabilities The Summit Medical Systems-designed database report-making capabilities are similar to those of the adult cardiac surgery database and include the ability to generate lists based on the entire population or subsets (Table 1), perform numerical and statistical analyses (Table 2), and transform raw data into graphs and slides using a Harvard Graphics program. General or specific subset population s u m m a r y reports are available for length of stay, mortality by age, complications, diagnostic or procedural field tallies, and referring physicians (Table 3).
Customization One of the goals of the subcommittee was a database that supplied sufficient information to fulfill its objectives, a reliable count of congenital heart surgical procedures and sufficient data for potential risk analysis. The subcommittee curtailed the n u m b e r of items on the data collection form so that the database would appeal to all types of practices, eg, solo, group, hospital-based, and academic hospital-based. Summit Medical Systems (or a trained user) can customize an individual center's forms and database to add fields of interest to the center. In the national analysis of data, only data fields of the official STS database form would be accessed, not customized data fields. Fields added for clinical research or other
Table 2. Biostatistics Menu
Numeric field analysis Generate study data file Kaplan-Meier survival Chi-Square analysis Independent t test analysis Paired t test analysis Linear regression analysis Return to analysis menu
556
REPORT STS C O N G E N I T A L HEART SURGERY DATABASE
Table 3. Population Summary Reports Length of stay report Mortality by age report Complications summary Annual summary report Event per patient summary Independent patient trend summary Monthly summary report Multifield tally Referring physician report Ten-year trend analysis Unique patient count
center-driven needs w o u l d not be analyzed. At this time, only a few centers have h a d the database installed a n d operating for a full year. The committee plans to have participating centers send in their data to S u m m i t M e d ical Systems in early 1995 so that we will be able to r e p o r t on the data analysis by the u p c o m i n g national cardiothoracic meetings. The data analysis will focus on the more basic capabilities of the database, eg, e n u m e r a t i o n s of specific procedures or diagnoses, computations of length of stay b y
A n n Thorac S u r g 1995;59:554-6
specific p r o c e d u r e s or diagnoses, sex, age, a n d race distributions. These data then will be available for analysis, forecasting, or p l a n n i n g on institutional a n d national levels, so necessary in today's competitive m a n a g e d care market. The Subcommittee foresees the possibility that in this initial analysis of data we also will detect relationships that will aid in more sophisticated analyses of risk stratification for specific p r o c e d u r e s a n d diagnoses. The S u b c o m m i t t e e urges all existing congenital heart surgery p r o g r a m s to strongly consider the database initiative in the expectation that this will help us all attain our goals.
Constantine Mavroudis, MD, Chair Edward L. Bove, M D Duke E. Cameron, M D Davis C. Drinkwater, Jr, M D Fred H. Edwards, M D John W. Hammon, Jr, M D Irving L. Kron, M D John E. Mayer, Jr, MD Robert J. Szarnicki, M D Donald C. Watson, Jr, M D Marc Schwartz, BS Melanie Gevitz, BA
The Society of Thoracic Surgeons' National Congenital Heart Surgery Database the May 1990 meeting of The Society of Thoracic A t Surgeons' (STS) Ad-Hoc Committee to Develop a National Database for Thoracic Surgery, a special subcommittee was named by Chairman Richard Clark to develop a database for congenital heart surgery. During the course of many meetings, several database formats were considered and discarded; in April 1993 consensus was achieved and the current database collection form was finalized and made available to those interested in purchasing the program from Summit Medical Systems. Why a national database for congenital heart surgery? Extant databases embrace congenital heart surgery; however, congenital heart surgery data collection is incidental to their primary data collection objectives and a significant subgroup of the congenital heart surgery population is excluded from the various databases; eg, neonatal databases exclude older patients; university hospital databases exclude those patients operated on in nonuniversity hospital settings. State governments are inconsistent in their legislative mandates and funding for data collection; not all states mandate health data collection and, of those, the mandates vary from expansive (and expensive) data collection to narrowly defined data collection for specific disease entities or population subsets. With increasing pressure placed on practitioners by third-party agencies (governmental and private) to provide reliable data on surgical experience, the STS Database Committee charged the subcommittee to develop a database that would (1) provide a reliable count of congenital heart surgical procedures and (2) provide outcome data with the potential for risk factor analysis. The initial database collection form was modeled after the STS Adult Cardiac Surgery form; there are sections on demographics, patient history, diagnosis, procedure, cardiopulmonary bypass and support data, and postoperative data, with items within each category that were agreed upon by the subcommittee as being significant to congenital heart surgery data collection and analysis. The alpha test site of the first Summit Medical Systems version of the Congenital Heart Surgery Database program was Children's Memorial Hospital, Chicago, in October 1991. Subsequent major conceptual and minor fine-tuning revisions to the database were made as a result of problems that arose at the alpha site when the database program had to be adapted to the realities of the complex congenital heart surgery patient population. Among the conceptual issues that needed defining by the subcommittee were the following: is a separate database form to be completed for each procedure or for each hospitalization period; how does one differentiate and Address reprint requests to Dr Mavroudis, Division of CardiovascularThoracic Surgery, The Children's Memorial Hospital, 2300 Children's Plaza-M/C #22, Chicago, IL 60614.
© 1995 by The Society of Thoracic Surgeons
weight the multiple diagnoses some of the congenital heart patients have--is one diagnosis more significant than another, are two diagnoses significant and four others less so; how does one portray the patient who has had an operation for one diagnosis in the past and now is admitted for another operation for a different problem; how does one differentiate from many potential diagnoses the diagnosis that drives the current procedure; how does one compile a procedure list--by providing hundreds of specific isolated procedures and combinations of procedures, or by providing components so that the procedure can be built from components into a whole; and how does one indicate a second or third procedure performed during a hospitalization period? If a separate database form is completed for each procedure, complete information is acquired surrounding the events of the procedure. However, for a child requiring two operations in one admission, the whole may be greater than the sum of its parts. Were the operations staged, planned procedures or reoperations for residual defects or rescue procedures? In calculating length of stay data, if two separate forms were used, the length of stay data for the specific procedure would skew future length of stay analysis of that procedure. The subcommittee decided that the hospital admission was the definer of the database collection form, not the individual procedure, recognizing that in some instances data relevant to particular procedures would be lost (eg, when a closed heart procedure was performed first and an open heart as the second procedure, the cardiopulmonary bypass data would be sacrificed). The concept of applying a primary or secondary label to a diagnosis was arrived at easily by the subcommittee, and it was agreed that there could be more than one primary diagnosis. A remote repair designation was developed to indicate a diagnosis repaired in the past that is not being addressed at the current procedure but is still significant to an understanding of the patient's condition, ie, a patient who has undergone an arterial switch procedure in the past for transposition of the great arteries but who is now admitted for an operation to relieve pulmonary stenosis. The transposition of the great arteries is a remote repair diagnosis, the pulmonary stenosis the primary diagnosis. Another challenge to the subcommittee was how to designate, in the instances where a patient has multiple diagnoses, which of the diagnoses were being addressed by the current procedure. The section on diagnosis for current procedure was devised to accurately depict which diagnosis was being addressed by the operation. The subcommittee recognized that although the section is redundant for patients with isolated defects, it is Ann Thorac Surg 1995;59:554-6 • 0003-4975/95/$9.50 0003-4975(94)00947-6
Ann Thorac Surg 1995;59:554-6
important for infants and children with complex multiple defects. After work was done for some months at the alpha site with a lengthy list of procedures, it became clear that the list had the potential for unlimited expansion and would quickly become unwieldy; therefore, the subcommittee decided upon a component approach to the procedure section that would allow flexibility in coding without length. A Rastelli procedure, for instance, would include a ventricular septal defect closure and conduit placement. The ventricular septal defect closure field and the valve and valved conduit field allowed specifics of the techniques to be entered that a single field for Rastelli would not have allowed without multiple listings. Within the component field the subcommittee also arrived at the solution to the problem a second, or third, procedure within a hospitalization posed for the database. If a subsequent procedure was done it could be entered within the components as 2nd Op (or 3rd Op if necessary). As we write this, changes have been approved to the database collection form and program, most notably the ability to link in the report-making capability of the database a patient's name and a short diagnosis/procedure characterization. As entries and analyses of data are made nationally, changes and corrections to the current form may be necessary. The Subcommittee has agreed that suggested amendments to the collection form be reviewed on a yearly basis.
Personnel Accurate and complete data collection, consistent data entry, objective data analysis, and timely data maintenance are the cornerstones of an effective patient database. In telephone surveys of the first 30 users of the database, the subcommittee found that the individual cardiac surgery practices used office, nursing, and hospital technical staff to perform data collection and data entry. In some practices, a physician assistant or registered nurse gathered all data; in others, demographic data were completed by office staff, preoperative and postoperative data were gathered by fellows or resident staff, and intraoperative data were provided by perfusionists. Many practices had more than one database tracking different patient populations (adult cardiac surgery, adult thoracic surgery, cardiac transplantation, congenital cardiac surgery) and it was more usual for these groups to have one full-time person responsible for data collection, data entry, and data analysis. Selecting one person to be responsible for coordination of data entry and data analysis emerged as one of the most important means of assuring valid and reliable data entry and retrieval. Particularly in those practices that relied on short-term fellow or resident staff to complete data forms, it was found that data quality and consistency varied with changes of personnel. By having one data entry person capable of assessing and completing/editing/correcting data forms, data reliability could be assured. Summit Medical Systems has a training program for the individ-
REPORT STS CONGENITALHEARTSURGERYDATABASE
555
Table 1. Data Analysis Menu
Search/listing reports menu Frequency tables menu Population summary reports Biostatistics menu Presentation graphics Define population subset Define module relationships Predefined reports Return to access menu
uals who will be the primary users of the database available at their homesite in Minnesota, and this program is helpful, especially for those centers requiring customization of their database or sophisticated report formatting or data analysis.
Report-Making Capabilities The Summit Medical Systems-designed database report-making capabilities are similar to those of the adult cardiac surgery database and include the ability to generate lists based on the entire population or subsets (Table 1), perform numerical and statistical analyses (Table 2), and transform raw data into graphs and slides using a Harvard Graphics program. General or specific subset population s u m m a r y reports are available for length of stay, mortality by age, complications, diagnostic or procedural field tallies, and referring physicians (Table 3).
Customization One of the goals of the subcommittee was a database that supplied sufficient information to fulfill its objectives, a reliable count of congenital heart surgical procedures and sufficient data for potential risk analysis. The subcommittee curtailed the n u m b e r of items on the data collection form so that the database would appeal to all types of practices, eg, solo, group, hospital-based, and academic hospital-based. Summit Medical Systems (or a trained user) can customize an individual center's forms and database to add fields of interest to the center. In the national analysis of data, only data fields of the official STS database form would be accessed, not customized data fields. Fields added for clinical research or other
Table 2. Biostatistics Menu
Numeric field analysis Generate study data file Kaplan-Meier survival Chi-Square analysis Independent t test analysis Paired t test analysis Linear regression analysis Return to analysis menu
556
REPORT STS C O N G E N I T A L HEART SURGERY DATABASE
Table 3. Population Summary Reports Length of stay report Mortality by age report Complications summary Annual summary report Event per patient summary Independent patient trend summary Monthly summary report Multifield tally Referring physician report Ten-year trend analysis Unique patient count
center-driven needs w o u l d not be analyzed. At this time, only a few centers have h a d the database installed a n d operating for a full year. The committee plans to have participating centers send in their data to S u m m i t M e d ical Systems in early 1995 so that we will be able to r e p o r t on the data analysis by the u p c o m i n g national cardiothoracic meetings. The data analysis will focus on the more basic capabilities of the database, eg, e n u m e r a t i o n s of specific procedures or diagnoses, computations of length of stay b y
A n n Thorac S u r g 1995;59:554-6
specific p r o c e d u r e s or diagnoses, sex, age, a n d race distributions. These data then will be available for analysis, forecasting, or p l a n n i n g on institutional a n d national levels, so necessary in today's competitive m a n a g e d care market. The Subcommittee foresees the possibility that in this initial analysis of data we also will detect relationships that will aid in more sophisticated analyses of risk stratification for specific p r o c e d u r e s a n d diagnoses. The S u b c o m m i t t e e urges all existing congenital heart surgery p r o g r a m s to strongly consider the database initiative in the expectation that this will help us all attain our goals.
Constantine Mavroudis, MD, Chair Edward L. Bove, M D Duke E. Cameron, M D Davis C. Drinkwater, Jr, M D Fred H. Edwards, M D John W. Hammon, Jr, M D Irving L. Kron, M D John E. Mayer, Jr, MD Robert J. Szarnicki, M D Donald C. Watson, Jr, M D Marc Schwartz, BS Melanie Gevitz, BA